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Nextern

Designs and manufactures medical devices

Manufacturing Engineer 2

Manufacturing EngineeringConfirmed live in the last 24 hours
Full-timeCartago Province, Cartago, Costa RicaNo salary listed

About the Job

Requirements

  • A bachelor's degree in Electromechanical Engineering, Electrical Engineering, another field related to Medical Devices, or an equivalent combination of education and experience.
  • At least five years of related experience and/or training.
  • Advanced English proficiency.
  • A U.S. visa and availability to travel for periods of two to three months.
  • Excellent oral and written communication skills.
  • Strong organizational, problem-solving, and analytical skills.
  • Ability to manage priorities and workflow.
  • Versatility, flexibility, and willingness to work within changing priorities.
  • Attention to detail.
  • Knowledge of change control.
  • Ability to handle multiple projects and meet deadlines.
  • Good judgment and ability to make sound, timely decisions.
  • Knowledge of process validation.
  • At least five years of experience managing several production lines and multiple resources, preferably in highly regulated industries such as medical devices or pharmaceuticals.
  • Ability to coach operational and technical levels.

Responsibilities

  • Coordinate product enhancements with customers and internal project teams.
  • Review high-level design requirements to assess alignment with Nextern's core competencies and vision; review designs and determine required bills of materials.
  • Work with supply chain to obtain bill-of-materials pricing from internal and external vendors.
  • Address manufacturing issues related to product quality and cost.
  • Support customer calls and presentations to compile product-sustaining activities.
  • Help generate documentation supporting product development and manufacturing, including timelines, responsibilities, engineering protocols, IQ, OQ, and PQ reports, bills of materials, assembly instructions, manufacturing instructions, and procedures.
  • Help conduct component and device testing protocols.
  • Help develop plans to evaluate process repeatability and stability through equipment qualification and process validation.
  • Work with quality, supply chain, and product development to ensure compliance with QSR and internal protocols.
  • Work with internal manufacturing and outsourced partners to develop metrics such as labor time, yields, and statistical analysis, and to qualify and validate processes, tooling, and equipment.
  • Transfer engineering projects from engineering into manufacturing as required.

Desired Qualifications

  • Experience in highly regulated industries such as medical devices, pharmaceuticals, or similar fields.

About the Company

Nextern

Designs and manufactures medical devices

Nextern designs and manufactures medical devices for equipment makers, with engineering and factory teams involved from early prototypes through production. Its work includes catheter-based instruments and electronic systems used in minimally invasive treatment and diagnostic procedures. Customers pay for development and contract manufacturing services, with project costs shaped by device complexity, materials and production scale. Its clinical markets include vascular and heart interventions and nerve stimulation, with services sold separately or as an integrated program. Founded in 2000 with industrial engineering roots, Nextern shifted to medical devices in 2016 and is headquartered in Maple Grove, Minnesota.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Maple Grove, MN
Founded
2000

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